NCT04324242

Brief Summary

Transversus abdominis (TrA) is an important muscle for spinal stabilization. Abdominal draw-in maneuver (ADIM) is a method that selectively activates TrA without activating external oblique (EO) and internal oblique (IO) muscles. Individuals with low back pain may have some troubles to understand proper contraction of TrA. Therefore, to contract the TrA, two different feedback techniques have been used to instruct. In this observational study we aim to investigate the effects of two different biofeedback methods to teach patients the proper activation of TrA muscle using ADIM. We aim to find out the differences between visual and traditional tactile biofeedback and decide which one is practical and easy to teach the patients in clinical environment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

April 13, 2020

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
Last Updated

June 12, 2020

Status Verified

April 1, 2020

Enrollment Period

17 days

First QC Date

March 24, 2020

Last Update Submit

June 11, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • thickness change in TrA muscle

    thickness change in TrA muscle

    1 month

Secondary Outcomes (2)

  • thickness change in EO muscle

    1 month

  • thickness change in IO muscle

    1 month

Study Arms (2)

Group1

visual feedback

Other: abdominal hallowing maneuver

Group2

traditional feedback

Other: abdominal hallowing maneuver

Interventions

abdominal hallowing maneuver includes tucking navel in and up. To be able to control the effect of breathing it was instructed to start the maneuver at the end of the expiration. During the maneuver it was instructed to focus on increasing the thickness of TrA without increasing the thickness of IO and EO

Group1Group2

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

healthy volunteers between ages of 18-25 with no spinal problems.

You may qualify if:

  • healthy volunteers between ages of 18-25

You may not qualify if:

  • Volunteers excluded if they had (1) history of LBP, (2) spinal or abdominal surgeries, (3) neuromusculer or romatologic diseases. Each volunteer gave their informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Çankaya, 06530, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sevil Bilgin

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 27, 2020

Study Start

April 13, 2020

Primary Completion

April 30, 2020

Study Completion

September 15, 2020

Last Updated

June 12, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations